JEFFERSON INTERACTIVE ASTHMA CLINICAL RESEARCH GROUP

杰斐逊互动哮喘临床研究小组

• 批准号: 2519410
• 负责人: James E Fish
• 金额: $ 63.96万
• 依托单位: THOMAS JEFFERSON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1993
• 资助国家: 美国
• 起止时间: 1993-09-30 至 1998-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2519410
• 关键词: antiinflammatory agents; asthma; bronchodilators; clinical trials; colchicine; cooperative study; enzyme inhibitors; human subject; human therapy evaluation; leukotrienes; lipoxygenase; patient care management; respiratory disorder chemotherapy

This seeks to establish an interactive asthma clinical research group at Thomas Jefferson University. The overall goal of participating as part of a collaborative, multi-centered network is to explore novel approaches to the treatment of asthma and to create avenues for disseminating information gained from this research. The Jefferson Clinical Research Group would be based on existing comprehensive and multi-disciplinary research and clinical programs in asthma. Two protocols are proposed to evaluate novel approaches to the treatment of asthma. The first protocol examines the effects of colchicine in the long-term management of severe, steroid-dependent asthma. This is a double-blind, randomized, two-year study using numbers of hospitalizations, doctors' visits, and steroid requirements as primary efficacy measures. The second protocol is designed to define the anti-inflammatory potential of a leukotriene-D4 receptor antagonist and a 5-Lipoxygenase inhibitor and to determine whether either compound can serve as a corticosteroid substitute. For this study, the inflammatory component of asthma is defined as that component which is unresponsive to bronchodilator therapy, but responsive to steroid therapy. This is a double-blind, randomized fourteen-week study using pulmonary function, symptoms, and other drug use as primary outcome measures. A further aim of this proposal is to develop a patient stratification scheme based on clinical, demographic, and laboratory data with the goal of identifying subgroups of asthmatics who are most likely to benefit from a specific intervention and also to gain information regarding disease pathogenesis. The basic premise of this application is that asthma is not a single nosologic entity; rather, it is a syndrome comprising multiple disorders having common clinical manifestations but their own distinct pathogenetic mechanisms. Studies attempting to discern these differences are critical not only to achieve a better understanding of asthma, but also to enhance our ability to recognize the benefits of newer and more specific antiasthmatic agents.

该项目旨在建立一个互动的哮喘临床研究小组， 托马斯杰斐逊大学。 作为一部分参与的总体目标 一个协作的、多中心的网络是探索新的方法， 哮喘的治疗，并创造传播 从这项研究中获得的信息。 杰斐逊临床研究 集团将根据现有的综合和多学科 哮喘的研究和临床项目。 提出了两个协议， 评估治疗哮喘的新方法。 第一协议 研究了秋水仙碱在长期治疗严重， 类固醇依赖性哮喘 这是一项为期两年的双盲、随机、 使用住院次数、医生就诊次数和类固醇的研究 要求作为主要疗效指标。 第二协议是 旨在确定白三烯-D4的抗炎潜力， 受体拮抗剂和5-脂氧合酶抑制剂，并确定 这两种化合物是否可以作为皮质类固醇的替代品。 为 在这项研究中，哮喘的炎症成分被定义为 对支气管扩张剂治疗无反应，但对 类固醇治疗 这是一项为期14周的双盲随机研究， 使用肺功能、症状和其他药物使用作为主要研究 结果测量。 该提案的另一个目的是开发一种患者 基于临床、人口统计学和实验室数据的分层方案 目的是确定哮喘患者的亚组， 从特定的干预中获益， 关于疾病的发病机制。 本申请的基本前提是 哮喘不是一个单一的疾病分类实体，而是一种综合征， 包括具有共同临床表现的多种疾病， 它们各自独特的发病机制。 研究试图 辨别这些差异不仅对实现更好的 了解哮喘，也能提高我们认识哮喘的能力。 更新和更具体的抗哮喘药物的好处。